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A Pilot Prospective Randomized Trial of Postoperative Epoetin Alfa in Patients Undergoing Major Operation for Upper Gastrointestinal Malignancy

Grobmyer, Stephen R. MD*; Hemming, Alan W. MD*; Harris, Neil MD; Behrns, Kevin MD*; Logan, Henrietta PhD; Kim, Robin D. MD*; Chang, Myron PhD§; Cance, William G. MD*; Hochwald, Steven N. MD*

American Journal of Clinical Oncology: December 2009 - Volume 32 - Issue 6 - p 570-573
doi: 10.1097/COC.0b013e31819790a8
Original Article: Gastointestinal

Introduction: Strategies to reduce red blood transfusion utilization in cancer patients undergoing operation are needed. Hypothesis: Postoperative epoetin alfa (40,000 units subcutaneous on postoperative days 1 and 7) is associated with improved hematologic parameters in patients undergoing major abdominal surgery for malignancy.

Materials and Methods: Prospective, blinded, randomized trial of epoetin alfa (40,000 units subcutaneous on postoperative days 1 and 7) versus placebo in patients undergoing major abdominal operation for malignancy. Primary endpoints were immature reticulocyte fraction, reticulocyte count, and hemoglobin, which were measured on postoperative days 4, 7, and between 14 and 20. Secondary endpoints were transfusions and complications in the 2 groups.

Results: Forty patients were enrolled. There were no significant differences in immature reticulocyte fraction (P = 0.78), reticulocyte count (P = 0.42), or hemoglobin (0.35) in patients randomized to receive epoetin alfa versus placebo. There was no significant difference in red blood cell transfusion rate or postoperative complications in patients who received epoetin alfa compared with placebo.

Discussion: The use of postoperative epoetin alfa (40,000 units subcutaneous on postoperative days 1 and 7) in patients undergoing major operation for abdominal or pelvic malignancy is not supported by this randomized trial.

From the *Departments of Surgery, †Pathology and Laboratory Medicine, and ‡Community Dentistry and Behavioral Science, University of Florida, Gainesville, FL; and §Division of Biostatistics, Department of Epidemiology and Health Policy Research, University of Florida, Gainesville, FL.

Supported by the Ortho Biotech, LC.

All authors affirm the originality of this work and its presentation at the ASCO GI Cancer Symposium; January 2008; Orlando, Florida.

Reprints: Stephen R. Grobmyer, MD, Division of Surgical Oncology and Endocrine Surgery, PO Box 100286, 1600 SW Archer Rd, Gainesville, Florida. E-mail: Stephen.Grobmyer@surgery.ufl.edu.

© 2009 Lippincott Williams & Wilkins, Inc.